水痘减毒活疫苗接种不良反应监测结果分析

An analysis on the surveillance results of safety of post-marketing immunization of varicella attenuated live vaccine in Henan Province

目的了解河南省水痘减毒活疫苗(varicella attenuated live vaccine,Var V)预防接种的不良反应发生状况,评价Var V预防接种的安全性。方法通过中国免疫规划信息管理系统收集2011—2016年河南省报告的Var V不良反应个案和Var V接种数据,采用描述性流行病学方法进行分析。结果 2011—2016年河南省共报告Var V不良反应686例,年均报告发病率为16.89/10万剂,不良反应报告发生率呈逐年升高趋势(P=0.017)。病例以1~<2岁为主,占80.61%,报告发生率为13.62/10万剂;4—6月份不良反应报告最多,占32.80%,报告发生率为5.54/10万剂;报告病例主要集中在郑州市、洛阳市、周口市和信阳市。不良反应发生时间主要在第1剂次接种后和接种后的1 d内,分别占全部发生数的94.90%和72.89%。Var V不良反应临床表现以发热、红肿、硬结和一过性过敏反应为主,过敏性休克报告发生率为0.37/10万剂,热性惊厥报告发生率为0.12/10万剂。结论河南省Var V不良反应报告发生率逐年升高,疫苗安全性总体良好,但需关注过敏性休克、热性惊厥等严重异常反应的发生。

Objective To analyze the characteristics of adverse reactions for varicella attenuated live vaccine（Var V） in Henan Province from 2011 to 2016,in order to evaluate the immunization safety related to Var V. Methods The adverse reaction data and vaccination doses of Var V in Henan Province from 2011 to 2016 were collected through the China Information Management System for Immunization Programming. The descriptive methodology was used for data analysis.Results A total of 686 adverse reactions cases were reported in Henan Province from 2011 to 2016, and the average reported incidence rate was 16.89 per 100 000 dose. The ratio of male to female was 1.14∶1,and 80.61% cases occurred between 1 and 2 years old,and the reported incidence rate was 13.62 per 100 000 dose. And 32.80% cases were reported from April to June, and the reported incidence rate was 5.54 per 100 000 dose. The cases were mainly concentrated in Zhengzhou,Luoyang,Zhoukou and Xinyang. Most cases occurred after the first dose and within 1 d after vaccination. The main diagnoses of adverse reactions were fever, local swelling, indurations and transient anaphylactic disorders. The reported incidence rate of anaphylactic shock and fever convulsion were 0.37 per 100 000 dose and 0.12 per 100 000 dose respectively. All cases were recovered or got better. Conclusion The safety of Var V was good in Henan Province.However, the surveillance should focus on the anaphylactic shock and fever convulsion and other serious rare adverse reaction.